Nanochip Technology for B-Cell Lymphoma

Overseen By Lily Yang

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Ohio State University Comprehensive Cancer Center

Disqualifiers: Transformed lymphomas, CNS lymphoma, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 3

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new nanochip technology for individuals with diffuse large B-cell lymphoma (DLBCL). The goal is to evaluate how well the nanochip monitors patient responses to treatment and detects cancer recurrence. Researchers will test participants' blood at various points during and after chemotherapy to assess the technology's effectiveness. Those newly diagnosed with DLBCL and planning to receive all treatment at Ohio State University may be suitable candidates. As an unphased trial, this study provides a unique opportunity to contribute to groundbreaking research in cancer monitoring technology.

Do I need to stop my current medications for the trial?

The trial protocol does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.

What prior data suggests that this nanochip technology is safe for monitoring treatment response in B-cell lymphoma?

Studies have not yet determined the safety of the ILN biochip test for monitoring diffuse large B-cell lymphoma. However, similar technologies, such as CAR T-cell therapy, have been used safely in other treatments.

A study in a "Not Applicable" phase often focuses on gathering information rather than thoroughly testing safety, which may result in limited details on potential side effects or risks.

Participants should discuss any concerns with the trial team and request more information about current safety knowledge. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about using molecular nanotechnology for B-cell lymphoma because it offers a unique diagnostic approach. Unlike traditional treatments that focus solely on eradicating cancer cells, this method employs ILN biochip testing to provide real-time insights into the disease's progression. By analyzing blood samples at multiple stages, it allows for more personalized treatment adjustments and potentially earlier detection of relapses. This cutting-edge technology could lead to more effective and tailored treatment strategies for patients.

What evidence suggests that this nanochip technology is effective for monitoring treatment response in B-cell lymphoma?

Research shows that the immuno-tethered lipoplex nanoparticle (ILN) biochip is a promising development in cancer care. This tiny chip checks treatment effectiveness and detects cancer recurrence in patients with diffuse large B-cell lymphoma by analyzing blood samples. In this trial, participants will undergo ILN biochip testing at diagnosis, before and after each chemotherapy course, every 3 months for 2 years, and at relapse. While researchers are still studying its effectiveness for this specific cancer type, nanotechnology has shown promise in diagnosing and targeting tumors. Early results suggest these technologies could help doctors monitor the disease more precisely. However, its exact effectiveness for diffuse large B-cell lymphoma remains under investigation. ^{1 2 4 6 7}

Who Is on the Research Team?

Beth Christian, MD

Principal Investigator

Ohio State University Comprehensive Cancer Center

Are You a Good Fit for This Trial?

This trial is for people with a specific blood cancer called diffuse large B-cell lymphoma (DLBCL) who haven't been treated before. Participants must plan to get all their care at Ohio State University, aim for a cure with treatment, and go through 6 cycles of chemotherapy. They also need to be able to give consent.

Inclusion Criteria

You must plan to receive all treatment and follow-up care at Ohio State University (OSU).

I have a specific type of untreated lymphoma.

I am undergoing treatment aimed at curing my condition.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Chemotherapy

Participants undergo chemotherapy with ILN biochip testing before and after each course

Varies per participant

Multiple visits for each chemotherapy course

Monitoring

Participants' blood samples undergo ILN biochip testing every 3 months for 2 years to monitor treatment response and detect relapse

24 months

Every 3 months

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Molecular Nanotechnology

Trial Overview The study is testing nanochip technology (ILN biochip) to see how well it can monitor the effectiveness of treatments in real-time and detect any return of the disease in patients with DLBCL. Researchers are looking for genetic markers that could predict treatment outcomes.

How Is the Trial Designed?

Group I: Diagnostic (ILN biochip testing) Experimental Treatment 1 Intervention

Participants' blood samples undergo ILN biochip testing at diagnosis, before and after every course of chemotherapy, every 3 months for 2 years, and at relapse.

Who Is Running the Clinical Trial?

Ohio State University Comprehensive Cancer Center

Lead Sponsor

Trials

350

Recruited

295,000+

Published Research Related to This Trial

CAR-T cell therapy shows promising efficacy in treating relapsed/refractory B-cell lymphoma, particularly in older patients and those with specific pathological types, achieving high response and complete remission rates across 17 studies.

While the treatment is generally safe, with most side effects like cytokine-releasing syndrome (CRS) and neurotoxicity being reversible, careful monitoring of these toxicities is essential during clinical application.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Efficacy and safety of chimeric antigen receptor-T cells in the treatment of B cell lymphoma: a systematic review and meta-analysis. Zheng, XH., Zhang, XY., Dong, QQ., et al.[2023]

In a phase 1 clinical trial involving 14 patients with relapsed/refractory acute lymphoblastic leukemia (ALL) and non-Hodgkin lymphoma (NHL), the novel Sleeping Beauty (SB) CD19-specific CAR T-cell therapy demonstrated a strong safety profile, with no serious adverse events directly linked to the treatment and only mild cytokine release syndrome observed.

Efficacy results showed that 38% of patients with ALL achieved complete remission or incomplete count recovery, and 50% of patients with diffuse large B-cell lymphoma (DLBCL) also achieved complete remission, indicating promising antitumor activity of the SB-based CAR constructs.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Sleeping beauty generated CD19 CAR T-Cell therapy for advanced B-Cell hematological malignancies. Singh, H., Srour, SA., Milton, DR., et al.[2023]

Chimeric antigen receptor (CAR) T-cell therapies have shown promising results in treating patients with relapsed or refractory B-cell non-Hodgkin lymphoma, offering complete and lasting clinical responses where traditional therapies have failed.

Four CD19-directed CAR T-cell therapies have been approved by the FDA for specific types of relapsed or refractory lymphomas, indicating a significant advancement in treatment options for these challenging cases.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Relapsed/Refractory Non-Hodgkin Lymphoma: Engineering T-Cells to Express Chimeric Antigen Receptors (CARs), a Salvage? Kanwal, B.[2021]

In a phase I study involving 10 patients with refractory diffuse large B-cell lymphoma (DLBCL), the anti-CD19 CAR T cell therapy (C-CAR011) demonstrated a 50% overall response rate at 12 weeks, indicating promising efficacy for this treatment.

The therapy showed a favorable safety profile, with 90% of patients experiencing cytokine release syndrome but no severe (grade ⩾ 3) cases or neurotoxicity, suggesting it is a safe option for patients with heavily treated DLBCL.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Phase I study of CBM.CD19 chimeric antigen receptor T cell in the treatment of refractory diffuse large B-cell lymphoma in Chinese patients. Fan, L., Wang, L., Cao, L., et al.[2022]

Citations

1. clinicaltrials.gov clinicaltrials.gov/study/NCT03656835

Study Details | NCT03656835 | Nanochip Technology in ... It is not yet known how well ILN biochip-based testing monitors treatment response or detects relapse in participants with diffuse large B-cell lymphoma.

2. withpower.com withpower.com/trial/phase-lymphoma-8-2018-51d93

Nanochip Technology for B-Cell Lymphoma This trial uses a special tiny chip to monitor treatment response and detect relapse in patients with diffuse large B-cell lymphoma by checking their blood ...

3. nature.com nature.com/articles/s41392-024-01889-y

Current advance of nanotechnology in diagnosis and ... This review presents a literature overview and summary of how nanotechnology is used in the diagnosis and treatment of malignant tumors.

4. clinicaltrials.gov clinicaltrials.gov/study/NCT07181785

Molecular Characterization and Outcomes of Aggressive B ... This is a retrospective analysis of the presence of chromosomal rearrangements involving MYC, BCL2 and BCL6 genes by FISH in a retrospective, ...

5. molecular-cancer.biomedcentral.com molecular-cancer.biomedcentral.com/articles/10.1186/s12943-023-01865-0

Progressing nanotechnology to improve targeted cancer ... This study highlights the various nanocarriers and compounds that can be used for selective tumor targeting and the inherent difficulties in cancer therapy.

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11889632/

Lymphoma-on-chip model reveals that lymph node stromal ... This lymphoma-on-chip model reveals the important role of LNSCs in DLBCL progression, and offers an innovative tool to study the DLBCL microenvironment.

7. sciencedirect.com sciencedirect.com/science/article/pii/S1535610825002284

Large B cell lymphoma microenvironment archetype profiles High-confidence malignant B cells were identified using an ensemble of molecular features (Figure S1A). Cells were separated into major lineages ...